New Asthma Treatment Shows Tremendous Promise in Phase II Trial.

Business Editors/Health/Medical Writers

BIOWIRE2K

LONDON--(BUSINESS WIRE)--June 11, 2003

Study published in European Respiratory Journal shows Britannia Pharmaceutical's Pumactant abolished early asthmatic responses in all subjects

Results of a study published this month in the European Respiratory Journal show that Pumactant, developed by Britannia Pharmaceuticals, has the potential to be a significant advance in the prevention of asthma attacks for the millions of asthma sufferers worldwide. This novel dry powder for inhalation mimics the bodies own lining of the lungs, and may increase the ability of the lungs to protect themselves from irritants.

"The results of this trial are extremely exciting," said Professor Stephen Holgate, MRC Clinical Professor of Immunopharmacology at the University of Southampton School of Medicine. "The dramatic effects we observed have led us to believe that Pumactant has remarkable potential for asthma sufferers - protecting them not only from allergens, but from a variety of irritants that exacerbate respiratory distress."

The Phase II clinical trial, conducted by Dr. Joy Conway and Professor Stephen Holgate at the University of Southampton School of Medicine, was a randomized, single-blind, prospective, cross-over study designed to evaluate the effects of Pumactant on early and late asthmatic responses in patients. All the patients in the trial were non-smokers who had a history of mild asthma.

At the start of the trial, subjects were randomly selected to receive either inhaled Pumactant or a placebo. Subsequently, all subjects were given a standard bronchial provocation test, during which they inhaled five breaths of increasing concentrations of allergens. In each of the treated subjects, early asthmatic response - shortness of breath from bronchial constriction that occurs within 15 minutes of exposure to the allergen - were completely abolished. Pumactant's effect on late asthmatic responses, which occur 3 to 10 hours after exposure to the allergens, was less dramatic but still promising.

In all subjects treated with Pumactant, there were no significant side effects.

A common feature of respiratory distress is a change in pulmonary surfactant, which is the surface lining of the lungs and is comprised of a complex mixture of phospholipids, neutral lipids and proteins. Researchers have indicated that the probable key to Pumactant's effectiveness in the prevention of asthma attacks is its ability to enhance the disrupted surfactant, thus protecting lung tissues from allergens or other environmental insults.

"Asthma can be very difficult to treat," said Maxwell Noble, Managing Director of Britannia Pharmaceuticals. "Many asthma medications have serious side-effects that hinder patient compliance. This new and natural approach, which works on entirely different principles than the asthma medications currently on the market, could provide relief to those asthma sufferers who have not had success with available treatments."

A mixture of two naturally occurring phospholipids, Dipalmitoylphosphatidycholine (DPPC) and Phosphatidyl Glycerol (PG), Pumactant was originally developed in a liquid form by Britannia in collaboration with Addenbrookes Hospital (Cambridge, UK) in 1987. In addition to asthma, Britannia is currently testing a different version of the patented powder formulation for the prevention of surgical adhesions.

Also this month, in a separate publication at the International Society for Aerosols in Medicine congress in Washington D.C., USA, Britannia revealed the progress it has made in developing a hand-held device capable of delivering Pumactant into the lungs. The continued development of this patented device will facilitate the start of later stage phase II clinical studies within the next year.

About Britannia Pharmaceuticals

Founded in 1981 Britannia Pharmaceuticals Limited is a United Kingdom based pharmaceutical firm whose mission is to become a leading supplier of innovative products for niche medical conditions. The company has pioneered new treatments for some of the world's most debilitating conditions including asthma, Parkinson's disease, drug addiction, erectile dysfunction and surgical adhesions. In addition to these treatments, Britannia has also developed nasal and respiratory drug delivery technologies that are applicable to a wide range of treatments. Britannia is a Forum Bioscience Company. The website address is www.britannia-pharm.co.uk.